EUCTR2018-000853-29-ES进行中（未招募）1 期
Treatment of chemo-refractory viral infections after allogeneicstem cell transplantation with multispecific T cells against CMV, EBV and AdV: A phase III, prospective, multicentre clinical trial - Multivirus-specific T-cell transfer post SCT vs AdV, CMV and EBV infections (TRACE)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 149
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult or paediatric patients (>2 months of age) after HSCT (no time restrictions apply) suffering from new or reactivated CMV, EBV or AdV infection and refractory to standard antiviral treatment for two weeks (defined as =1 log decrease in viral load over two weeks) as confirmed by quantitative blood PCR analysis
- •2. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection
- •3. Written informed consent given (patient or legal representative)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 98
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Acute GvHD > grade II or extensive chronic GvHD at time of IMP transfer
- •2. Treatment with steroids (>1 mg/kg Prednisone equivalent) at Screening
- •3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. In case of T-cell depleted HSCT, a prescheduled prophylactic DLI =3 x 10e5 T cells/kg BW is not considered an exclusion criteria.
- •4. Organ dysfunction or failure as determined by Karnofsky (age >16 years) or Lansky (age =16 years) score =30%
- •5. Concomitant enrolment in another clinical trial interfering with the endpoints of this study
- •6. Any medical condition which could compromise participation in the study according to the investigator’s assessment
- •7. Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study
- •8. Second line or experimental antiviral treatment other than Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab from Screening until 8 weeks after IMP infusion or prophylactic treatment other than Aciclovir or Letermovir throughout the study except approved by sponsor
- •9. Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test.
- •10. Female patient who is pregnant or breast-feeding, or adult of reproductive potential not willing to use an effective method of birth control from Screening until the last follow-up visit (FU6, Visit 8) Note: women of childbearing potential must have a negative serum pregnancy test at study entry
- •11. Known hypersensitivity to iron dextran
- •12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
研究者
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